Prescription drug · ANDA
Ramelteon NDC 76420-880
Ramelteon 8 mg/1 · Tablet, Film coated · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-880-01 | 76420088001 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-880-01)Marketed from Jan 17, 2025 | |
| 76420-880-30 | 76420088030 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-880-30)Marketed from Jan 17, 2025 | |
| 76420-880-60 | 76420088060 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-880-60)Marketed from Jan 17, 2025 | |
| 76420-880-90 | 76420088090 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-880-90)Marketed from Jan 17, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ramelteon
- Generic name (nonproprietary)
- ramelteon
- Active ingredients
- Ramelteon — 8 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215972
- Marketing start
- Listing expires
- Other FDA classes
- Melatonin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 76420-880_2bea370a-97da-d286-e063-6294a90aca7fSPL ID 2bea370a-97da-d286-e063-6294a90aca7fSPL set ID 8213998f-9a14-4ebb-a87a-4f33416dfb21RxCUI 577348UNII 901AS54I69
- Pharmacologic class
- Melatonin Receptor Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476420088001followed by a unit qualifier and the quantityPackage 76420-0880-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 215972
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.